| Eligibility |
Inclusion Criteria:
For primary immunization stage:
- Subjects aged 6 months-5 years;
- Subjects should be full-term (37-42 weeks of gestation) and their birth weight should
meet the requirements (2500g = body weight = 4000g);
- Axillary body temperature = 37.0 ?;
- The guardian of the subject voluntarily agrees to the child's participation in the
study and signs an informed consent form;
- The guardians of the subjects have the ability to understand the research procedures
and participate in all planned follow-up visits;
- Infants and young children aged 6 to 23 months have not received the meningococcal
conjugate vaccine. If they have been vaccinated with group A meningococcal
polysaccharide vaccine, the interval between vaccination and the previous dose should
exceed 3 months;
- Children aged 2-5 who have not been vaccinated with meningococcal conjugate vaccine,
if they have been vaccinated with meningococcal polysaccharide vaccine (including
group A meningococcal polysaccharide vaccine, group A and C meningococcal
polysaccharide vaccine, and group ACYW135 meningococcal polysaccharide vaccine), the
interval between the last dose should exceed 12 months;
- Subjects had no vaccination history of other live attenuated vaccines (such as BCG
vaccine, live attenuated polio vaccine, rotavirus vaccine, etc.) within 14 days before
vaccination, and no vaccination history of other non live vaccines (such as hepatitis
B vaccine, inactivated polio vaccine, DPT vaccine, etc.) within 7 days.
- Subjects who have not been vaccinated with meningococcal group A and C conjugate
vaccine at the aged of 3-5 months;
- Subjects who had no history of other live vaccines within 14 days before vaccination
and no history of other inactivated vaccines within 7 days;
For booster immunization stage (applicable to the 6-11 month age group):
- Infants and young children who have been enrolled in this clinical trial between 6 and
11 months of age and have reached the age of 18 months;
- Infants and young children who have completed basic immunization in this clinical
trial;
- According to the opinions of the researchers, the subjects and their guardians are
able to comply with the requirements of the clinical trial protocol.
For immune persistence stage (applicable to the 12-23 month age group):
- Children who have been enrolled in this clinical trial at 12-23 months of age and have
completed basic immunization for 12 months; According to the researcher's opinion, the
subjects and their guardians are able to comply with the requirements of the clinical
trial protocol.
Exclusion Criteria:
For primary immunization stage:
- Have a history of severe allergic reactions that require medical intervention; Have a
history of allergies to vaccines or vaccine ingredients (such as lactose, sodium
chloride, tetanus toxoids, etc.), and other serious adverse reactions to vaccines;
- Has contraindications for intramuscular injection such as thrombocytopenia, any
coagulation dysfunction, or undergoing anticoagulant therapy;
- Has severely abnormal labor (dystocia, instrumental delivery, excluding cesarean
section), or history of asphyxia, neurological damage, in vitro fertilization or
multiple pregnancy, pathological jaundice (only applicable to infants and young
children aged 6-11 months);
- Suffering from serious congenital malformations or chronic diseases that may interfere
with the progress or completion of the study (including but not limited to Down's
syndrome, thalassemia (the first degree relatives in the family are thalassemia or
gene carriers of thalassemia), heart disease, kidney disease, diabetes, autoimmune
diseases (repeated perianal abscesses), hereditary allergies, Guillain Barre syndrome,
etc.);
- Infectious diseases with clinical or serological evidence, such as tuberculosis,
hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection or HIV infected
parents;
- Any situation resulting in splenomegaly, splenectomy, or functional splenomegaly;
- Has a history of convulsions, epilepsy, encephalopathy, and mental illness (including
family history);
- Within 3 days prior to the first dose of the vaccine, there was an acute illness or
acute exacerbation of a chronic disease, or the use of antipyretic, analgesic, and
anti allergic drugs (such as acetaminophen, ibuprofen, aspirin, etc.);
- Congenital or acquired immunodeficiency; Or receive systemic corticosteroid treatment
(any medication route, = 2mg/kg/day) for = 14 days within 3 months prior to
enrollment, such as prednisone, inhaled steroids budesonide, fluticasone, etc; Or
being using other immunosuppressants such as cyclosporine, tacrolimus, etc. before
enrollment;
- Has given immunoglobulin and/or any blood products (except hepatitis B immunoglobulin)
within 3 months before enrollment;
- Plan to move before the end of the study visit or leave the local area for a long time
during the scheduled study visit;
- Plan to participate or be participating in any other drug clinical research;
- According to the researcher's judgment, there are any other factors that are not
suitable for the subjects to participate in the clinical trial.
For booster immunization stage (applicable to the 6-11 month age group) and immune
persistence stage (applicable to the 12-23 month age group):
- Subjects in the experimental group aged 6-11 months received any meningococcal vaccine
before blood serum collection at 18 months old after completing basic immunization;
- Subjects in the 12-23 month age group were vaccinated with any meningococcal vaccine
before completing blood collection at 12 month post-completion of primary immunization
schedule;
- After participating in this clinical trial, the subjects are known or suspected to
have immunological deficiencies, including being treated with immunosuppressants (such
as radiation therapy, chemotherapy, corticosteroids, anti metabolic drugs, cytotoxic
drugs, etc.) and HIV infection;
- Subjects in the experimental group aged 6-11 month old were given immunoglobulin
and/or any blood products (except hepatitis B immunoglobulin) within 3 months before
the booster immunization.
- According to the researcher's judgment, there are any other factors that are not
suitable for the subjects to participate in the clinical trial
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